An Open-Label, Phase 1 Study to Characterize the Effects of a Strong Cytochrome P450 3A4 Inducer on the Pharmacokinetics of Bomedemstat in Healthy Adult Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Area under the concentration versus time curve from 0 to infinity (AUC0-inf) of bomedemstat
研究概览
简要总结
Researchers have designed a study medicine called bomedemstat (MK-3543) as a new way to treat certain rare blood diseases.
The purpose of this study is to learn what happens to bomedemstat in a person's body over time (a pharmacokinetic or PK study). Researchers will compare what happens to bomedemstat in the body when it is given alone and after multiple doses of another medicine called carbamazepine (CBZ).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The main inclusion criteria include but are not limited to the following:
- •Non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months before entering the study.
- •Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m^2
- •Medically healthy with no clinically significant medical history
排除标准
- •The main exclusion criteria include but are not limited to the following:
- •History or presence of any of the following:
- •Negative reactions in the blood system to any drugs
- •Depression, unusual changes in mood or behavior or suicidal thoughts or behavior
- •History of cancer
- •Regular user of cannabis products within 6 months before entering the study.
- •Unable to stop using or anticipates the use of any drugs, including prescription and non-prescription medications, herbal remedies, or vitamin supplements beginning 14 days before entering the study.
研究组 & 干预措施
Bomedemstat + Carbamazepine
A single dose of bomedemstat will be administered On Day 1 of Period 1. There will be a washout of 7 days between bomedemstat dosing in Period 1 and the first carbamazepine (CBZ) dose in Period 2. In Period 2, CBZ will be administered twice daily (BID) for 17 consecutive days, with a single dose of bomedemstat coadministered with the morning dose on Day 14.
干预措施: bomedemstat (Drug)
Bomedemstat + Carbamazepine
A single dose of bomedemstat will be administered On Day 1 of Period 1. There will be a washout of 7 days between bomedemstat dosing in Period 1 and the first carbamazepine (CBZ) dose in Period 2. In Period 2, CBZ will be administered twice daily (BID) for 17 consecutive days, with a single dose of bomedemstat coadministered with the morning dose on Day 14.
干预措施: carbamazepine (Drug)
结局指标
主要结局
Area under the concentration versus time curve from 0 to infinity (AUC0-inf) of bomedemstat
时间窗: Predose and at designated timepoints up to 168 hours postdose
AUC0-inf for bomedemstat in plasma will be determined
次要结局
- Number of participants who experience one or more adverse events (AEs)(Up to approximately 66 days)
- Number of participants who discontinue study treatment due to an AE(Up to approximately 25 days)
- Area under the concentration versus time curve from 0 to the time of the last quantifiable sample (AUC0-last) of bomedemstat(Predose and at designated timepoints up to 168 hours postdose)
- Area under the concentration versus time curve from 0 to 24 hours after dosing (AUC0-24) of bomedemstat(Predose and at designated timepoints up to 24 hours postdose)
- Maximum observed concentration (Cmax) of bomedemstat(Predose and at designated timepoints up to 168 hours postdose)
- Maximum observed concentration 24 hours after dosing (C24) bomedemstat(Predose and at designated timepoints up to 24 hours postdose)
- Time to maximum concentration (Tmax) of bomedemstat(Predose and at designated timepoints up to 168 hours postdose)
- Apparent terminal half-life (t1/2) of bomedemstat(Predose and at designated timepoints up to 168 hours postdose)
- Apparent clearance (CL/F) of bomedemstat(Predose and at designated timepoints up to 168 hours postdose)
- Apparent volume of distribution during terminal phase (Vz/F) of bomedemstat in plasma(Predose and at designated timepoints up to 168 hours postdose)